Unipolar Microplasma Radiofrequency Device: In-vivo Histologic Study
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|ClinicalTrials.gov Identifier: NCT04153071|
Recruitment Status : Withdrawn (Per Investigator and sponsor decision)
First Posted : November 6, 2019
Last Update Posted : September 25, 2020
Prospective, Open-Label, Single-Center Pilot Study.
The study is aimed to evaluate the histologic effects of a unipolar microplasma electrode pin radiofrequency device (Alma Lasers OPUS system) on the abdominal skin.
The study will include up to 2 subjects. Each subject will have a single cutaneous treatment of their lower abdomen, with variable treatment parameters. Punch biopsies will be obtained from each treatment section, for in-vivo histological evaluations.
|Condition or disease||Intervention/treatment||Phase|
|Skin Resurfacing||Device: OPUS system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Cutaneous Effects of a Unipolar Microplasma Electrode Pin Radiofrequency Device: An In-vivo Histologic Study|
|Actual Study Start Date :||October 23, 2019|
|Actual Primary Completion Date :||September 16, 2020|
|Actual Study Completion Date :||September 16, 2020|
Experimental: Unipolar microplasma RF treatment
Single cutaneous unipolar microplasma RF treatment, with variable treatment parameters
Device: OPUS system
Each subject will have a single cutaneous treatment of their lower abdomen, with variable treatment parameters. Punch biopsies will be obtained from each treatment section, for in-vivo histological evaluations.
- Diameter and depth of ablation and/or coagulation from varying RF device treatment parameters [ Time Frame: Immediately post treatment ]Histology analysis to evaluate the diameter and depth of ablation and/or coagulation from varying microplasma RF device treatment parameters, based on biopsy specimens
- Rate of adverse events [ Time Frame: 10 days ]Safety will be monitored by documentation of adverse events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04153071
|United States, Texas|
|Westlake Dermatology Clinical Research Center|
|Austin, Texas, United States, 78746|
|Principal Investigator:||Daniel Friedmann, MD, FAAD||Westlake Dermatology Clinical Research Center|